Exposure of human volunteers to live malaria sporozoites under chloroquine prophylaxis

Exposure of human volunteers to live malaria sporozoites under chloroquine prophylaxis - EHMI-8

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30242

Enrollment

Registered

2006-11-16

Start date

1007-01-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

malaria

Interventions

Volunteers will be exposed to infectious mosquitoe bites. They will be treated with chloroquine, and later with riamet.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy 18-45 y/o

Exclusion criteria

Exclusion criteria: Systemic disorders

Design outcomes

Primary

Measure	Time frame
Primary endpoints (parasitological): 1. A significant difference in time of thick smear positivity between exposed and control groups 2. A significant difference in parasitemia as measured by 18S Pf NASBA between exposed and control group 3. A significant difference in kinetics of parasitemia between exposed and control groups as measured by 18S Pf NASBA. 4. A difference in occurrence or height of fever between exposed and control groups.	—

Measure

Time frame

Primary endpoints (parasitological): 1. A significant difference in time of thick smear positivity between exposed and control groups 2. A significant difference in parasitemia as measured by 18S Pf NASBA between exposed and control group 3. A significant difference in kinetics of parasitemia between exposed and control groups as measured by 18S Pf NASBA. 4. A difference in occurrence or height of fever between exposed and control groups.

—

Secondary

Measure	Time frame
Secondary endpoints (immunological): 1. Significant differences in immune response between exposed and control volunteers 2. Significant differences in the outcome of in vitro functional malaria assays between exposed and control volunteers 3. Significant differences in cellular reactivity against Pf antigens 4. Significant differences in parasite VAR gene expression during infection 5. The identification of immune mechanisms that correlate with protection 6. The identification of potential vaccine candidates that correlate with protection Exploratory endpoints (pathophysiological): 1. To identify early changes in iron metabolism 2. To identify early plasma changes in endothelial activation markers 3. To identify early changes in flow-mediated vasodilatation (FMD)	—

Measure

Time frame

Secondary endpoints (immunological): 1. Significant differences in immune response between exposed and control volunteers 2. Significant differences in the outcome of in vitro functional malaria assays between exposed and control volunteers 3. Significant differences in cellular reactivity against Pf antigens 4. Significant differences in parasite VAR gene expression during infection 5. The identification of immune mechanisms that correlate with protection 6. The identification of potential vaccine candidates that correlate with protection Exploratory endpoints (pathophysiological): 1. To identify early changes in iron metabolism 2. To identify early plasma changes in endothelial activation markers 3. To identify early changes in flow-mediated vasodilatation (FMD)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)